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The purpose of this study is to characterize the pharmacokinetics (PK) of LY03004 following an escalating single intramuscular injection at 12.5, 25, 37.5, or 50 mg; and to evaluate the safety and tolerability and preliminary efficacy of LY03004 following intramuscular injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY03004- 12.5 | Experimental | LY03004 dosage strength at 12.5mg |
|
| LY03004 - 25 | Experimental | LY03004 Dose Strength 25mg |
|
| LY03004- 37.5 | Experimental | LY03004 Dose Strength 37.5mg |
|
| LY03004 - 50 | Experimental | LY03004 Dose Strength 50mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY03004 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax for the Pharmacokinetics (PK) of LY03004 | 43 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 43 Days | |
| The change of the PANSS score for the Preliminary efficacy of LY03004 | 43 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuropsychiatric Research Center of Orange County | Orange | California | 92868 | United States | ||
| Community Clinical Research Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38244179 | Derived | Wang W, Wang X, Dong Y, Walling DP, Liu P, Liu W, Shi Y, Sun K. Population Pharmacokinetic Analysis to Support and Facilitate Switching from Risperidone Formulations to Rykindo in Patients with Schizophrenia. Neurol Ther. 2024 Apr;13(2):355-372. doi: 10.1007/s40120-024-00578-w. Epub 2024 Jan 20. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Austin |
| Texas |
| 78754 |
| United States |